Doxil shortages exacerbated as Ben Venue shutters plant
pharmafile | November 22, 2011 | News story | Manufacturing and Production |Â Â Doxil, J&J, JJ, manufacturing and productionÂ
An acute shortage of Johnson & Johnson’s cancer drug Doxil (doxorubicin) in the US could get worse following a decision to suspend production at a manufacturing facility for the drug.
Contract manufacturing organisation Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim, has been forced to shutter its facility in Bedford, Ohio, in order to carry out essential maintenance work. The company has already said it intends to phase out its CMO operations in the coming years.
In a statement, the company said: “A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue.”
The plant has been involved in a series of product recalls in recent months, including supplies of indomethacin, doxycycline, famotidine and methotrexate injections, because of a range of quality issues including questions about sterility, as well as contamination with ethylene glycol and particulate matter.
Rob Bazemore, the president of J&J subsidiary Janssen Products which sells Doxil in the US, said he was ‘saddened’ by the news that Ben Venue has had to halt production at Bedford, noting that exacerbates the shortage of Doxil, which is currently only available to patients enrolled in the a physician access programme (PAP) set up to manage dwindling supplies.
No new patients will be eligible for inclusion in the PAP for Doxil until manufacturing capacity is restored, he added. It is estimated that around 2,700 patients are currently on the waiting list of the drug.
“We will continue our work to transition to an identified alternate supplier,” said Bazemore, although he noted that the complexity of Doxil manufacture means that this will occur over “an extended period of time”.
US President Barack Obama recently ordered the FDA and Department of Justice to take action to reduce and prevent medicine shortages, directing the agency to broaden its reporting of potential prescription drug shortages and speed up review of new manufacturing sites, drug suppliers, and manufacturing changes, amongst other measures.
Phil Taylor
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